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Sponsored by: |
Sarawak MediChem Pharmaceuticals |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00005120 |
The purpose of this study is to see if it is safe and effective to give calanolide A to HIV-infected adults who have not used anti-HIV drugs in the past.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Calanolide A |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Pharmacokinetics Study |
Official Title: | A Phase IB Study to Evaluate the Safety, Pharmacokinetics, and Effects of (+)-Calanolide A on Surrogate Markers in HIV-Positive Patients With No Previous Antiretroviral Therapy |
Estimated Enrollment: | 16 |
Study Start Date: | April 2000 |
Patients are randomized to receive (+)-calanolide A or placebo for 21 days. All patients may elect to receive an open-label, 3-month course of approved retroviral therapy (up to triple-drug therapy) to be selected by, and administered under the care of, the patients' physicians. If the patient has no insurance coverage or does not wish to utilize his/her insurance for anti-HIV medications, Sarawak MediChem Pharmaceuticals will provide these medications at no charge for up to 3 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
United States, Florida | |
South Florida Bioavailability Clinic | |
Miami, Florida, United States, 331813405 | |
United States, Illinois | |
Chicago Ctr for Clinical Research | |
Chicago, Illinois, United States, 60610 | |
The CORE Ctr | |
Chicago, Illinois, United States, 60612 | |
United States, Pennsylvania | |
Anderson Clinical Research | |
Philadelphia, Pennsylvania, United States, 19107 | |
Anderson Clinical Research | |
Pittsburgh, Pennsylvania, United States, 15221 | |
United States, South Carolina | |
Burnside Clinic | |
Columbia, South Carolina, United States, 29206 | |
United States, Texas | |
Univ of Texas Med Branch | |
Galveston, Texas, United States, 775550835 |
Study ID Numbers: | 297B, 57CL-0001 |
Study First Received: | April 20, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00005120 History of Changes |
Health Authority: | United States: Food and Drug Administration |
CD4 Lymphocyte Count Biological Markers Anti-HIV Agents |
Viral Load Pharmacokinetics calanolide A |
Virus Diseases Sexually Transmitted Diseases, Viral Anti-HIV Agents Anti-Retroviral Agents HIV Seropositivity HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Calanolide A Antiviral Agents Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Calanolide A Retroviridae Infections |